By Ben Guarino
August 23, 2021 at 4:15 p.m. EDT
Federal regulators on Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine — a milestone that could help increase inoculation rates and spark a wave of vaccine mandates by employers and universities amid a surge of new cases and hospitalizations fueled by the ferocious delta variant.
The Food and Drug Administration action marks the first licensing of a vaccine for the coronavirus, which has swept the United States in repeated and punishing waves since early 2020, exhausting nursing staffs, filling intensive care units and raising fears among the vaccinated and the unvaccinated.
The vaccine is approved for two doses, three weeks apart, in people 16 and older. It remains available under emergency use authorization for adolescents ages 12 to 15.
“As the first FDA-approved covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” FDA acting commissioner Janet Woodcock said in a statement.
Biden on FDA approval of Pfizer-BioNTech vaccine: ‘The moment you were waiting for is here’
President Biden touted the Food and Drug Administration’s full approval of the Pfizer-BioNTech coronavirus vaccine on Aug. 23. (The Washington Post)
President Biden touted the FDA’s full approval of the vaccine Monday and implored unvaccinated Americans to get the shot.
“Let me say this loudly and clearly,” he said in remarks from the White House. “If you’re one of the millions of Americans who said that they will not get the shot … until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for is here. It’s time for you to go get your vaccination and get it today.”
But some unvaccinated Americans said news of the FDA approval wasn’t enough to sway them, and others said they weren’t following regulators’ decision-making.
Ed Boone, 51, who lives in Oceana County, Mich., said he and his family weren’t aware the FDA had approved the vaccine until reached by a Washington Post reporter.
“We work in a bakery, so we’re here pretty early in the morning,” Boone said, adding that he wanted to do his own research on the FDA’s decision. “I’d want to see it for myself.”
Boone said he remained skeptical of the need for the vaccine, saying he’d already been infected by the coronavirus and noting that the delta variant had led to a rise in breakthrough infections.
“I know people that have had [the vaccine] — and they have still gotten the new variant. And I guess, if it doesn’t do anything for the new variant, what am I putting it in my body for?” Boone said.
Student Willie Webb, 20, receives a shot of the Pfizer coronavirus vaccine Aug. 20 at St. Thomas University in Miami. (Lynne Sladky/AP)
The president also renewed his call to public- and private-sector leaders to mandate vaccines. Last month, Biden announced he was requiring all federal workers to get vaccinated or comply with weekly testing.
“The reason most people in America don’t worry about polio, smallpox, measles, mumps and rubella today is because of vaccines,” Biden said. “It only makes sense to require a vaccine to stop the spread of covid-19. With today’s FDA full approval, there’s another good reason to get vaccinated.”
The Pentagon moved forward Monday with plans to mandate coronavirus vaccinations for U.S. troops following the Pfizer-BioNTech approval. The vaccine has been encouraged by commanders but was voluntary pending full authorization by the FDA, and Monday’s decision may accelerate the military’s timetable for mandating vaccination.
In New York, Mayor Bill de Blasio (D) decreed that all of the city’s public school teachers and staffers must be vaccinated. Under the mandate announced Monday, the city’s 148,000 public school employees cannot forgo vaccination and choose testing instead. They will be required to have at least one shot by Sept. 27.
Approval in record time
Critics for weeks had demanded that the FDA move faster on approving the vaccine, arguing that the millions of inoculations administered since late last year under an emergency authorization demonstrated the shots’ safety and effectiveness. But even as the FDA redoubled its efforts, increasing staff and computer resources dedicated to the review, the agency insisted on six months’ follow-up data for people enrolled in the pivotal clinical trial.
In the end, the vaccine approval was the fastest in the agency’s history, coming less than four months after Pfizer-BioNTech filed for licensing on May 7.
“It’s been remarkably fast,” said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania who said careful handling of the approval was crucial to potentially persuading the “vaccine hesitant” to receive the licensed product. “You can’t have it both ways. You can’t have people saying they won’t get vaccinated until there’s full approval and then say the FDA has to hurry up” and grant that approval.
Some experts predicted there would not be a huge bump in vaccinations following the approval, saying they were skeptical that vaccine-avoidant people would change their minds.
“It will provide an additional nudge but not make a huge difference,” said Jesse Goodman, a former FDA chief scientist who is a professor of medicine and infectious diseases at Georgetown University.
A recent surge in vaccinations, he said, appears to be driven by rising concerns about the delta variant.
Others predict the full licensure will lead to more vaccine requirements by colleges, workplaces, concert venues and movie theaters.
The approval of Pfizer-BioNTech’s vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said. The vaccine was 91 percent effective when preventing cases of covid-19, the illness caused by the virus, in that trial.
The company plans to follow the enrollees for 24 months. To qualify for FDA emergency use authorization last December, the company followed trial participants for a median of two months after getting their second shot.
“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer chief executive Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”
Unlike an emergency clearance, an approval lasts indefinitely, unless an unexpected side effect develops. To get a product licensed, a company must provide vastly more data and details on the manufacturing process and relevant facilities and is subject to in-depth inspections by the FDA. Pfizer’s manufacturing process will not change as a result of this approval. The vaccine, which Pfizer will market under the name Comirnaty, remains free to U.S. residents.
The FDA licenses not only the product but also “the process by which the vaccine is made and the manufacturing site,” said Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “There are protocols for every step of manufacturing, and that is not trivial.”
(Editor: Michael)
